Tempest Therapeutics (TPST) risk factors, FY2025 10-K

Tempest Therapeutics's FY2025 10-K, filed Mar 30, 2026, lists 90 risk factors in 8 groups. Against the prior year's 77: 23 new, 10 dropped, 25 substantially reworded.

Risk factors listed
908 groups
New this year
23vs 77 last year
Dropped
10since the prior 10-K
Substantially reworded
25of those kept
Section length
39k wordsItem 1A

What the changes say

  • Tempest added a dual-targeting CAR-T pipeline and clinical trial collaborations via an asset acquisition, while battling going concern doubts and a skeletal headcount.

What changed since the prior 10-K

New

  • New

    Our business is subject to numerous risks and uncertainties, any one of which could materially adversely affect our business, financial condition, operating results, and prospects. You should read this summary together with the more detailed description of each risk factor contained below

    We face substantial doubt regarding our ability to continue as a going concern due to our need for significant additional funding.

  • New

    Interim and preliminary data from our or our licensors’ clinical trials that we may announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data

    Interim and preliminary clinical trial data for TPST-2003 and TPST-2206 may change as more patient data becomes available.

  • NewRisks Related to Our Financial Position and Capital Needs

    Our existing cash and cash equivalents of $7.7 million as of December 31, 2025 is expected to fund our operations through less than 12 months from the date our consolidated financial statements are available to be issued

    Our existing cash of $7.7 million funds operations for less than 12 months, though we have $13.75 million available under a funding commitment from Factor.

  • NewRisks Related to Our Business and Strategy

    Integrating the Assets with our business may be more difficult, costly or time consuming than expected and we may fail to realize the anticipated benefits of the Asset Acquisition

    Integrating newly acquired CAR-T and other assets may be difficult, costly, or time-consuming, and we may fail to realize anticipated benefits.

  • NewRisks Related to Our Business and Strategy

    We are in the early stages of integrating the Assets into our business, and unknown or unanticipated risks associated with the Assets could adversely affect us

    We are in early stages of integrating new assets and may face unknown risks not identified during due diligence.

  • NewRisks Related to Our Business and Strategy

    We will need to expand our organization in the future, and we may experience difficulties in managing this growth, which could disrupt our operations

    As of March 1, 2026, we had only four full-time employees and will face difficulties managing future organizational expansion.

  • NewRisks Related to Our Product Development and Regulatory Approval

    Moreover, because our product candidates represent unproven methods for cancer treatment, potential patients and their doctors may be inclined to use existing therapies rather than enroll patients in our clinical trials

    Potential patients and doctors may prefer existing cancer therapies over our unproven product candidates.

  • NewRisks Related to Our Product Development and Regulatory Approval

    We plan to work with our collaborator, Novatim, to conduct clinical trials for TPST-2003 and TPST-2206 outside the United States, including China, and the FDA and similar foreign regulatory authorities may not accept data from such trials conducted in locations outside of their jurisdiction

    The FDA or foreign regulators may reject clinical trial data for TPST-2003 and TPST-2206 generated in China by our collaborator Novatim.

  • NewRisks Related to Our Product Development and Regulatory Approval

    Interim and preliminary data from our or our licensors' clinical trials that we may announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data

    Preliminary or interim clinical data may change materially following audit and verification procedures or as more patient data accrues.

  • NewRisks Related to Our Product Development and Regulatory Approval

    the product for distribution to patients and a communication plan to health care practitioners, or other elements to assure safe use of the product

    Undesirable side effects from our product candidates could result in suspended approvals, additional trials, or liability.

  • NewRisks Related to Commercialization and Manufacturing

    other third-party payors. Even if coverage is provided, the established reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment

    Uncertainty in insurance coverage and reimbursement amounts may prevent us from realizing sufficient return on investment.

  • NewRisks Related to Commercialization and Manufacturing

    the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us

    Third-party manufacturers, including Factor, Novatim, and CDMOs, may fail to comply with cGMP regulations.

  • NewRisks Related to Government Regulation

    effects observed early in clinical development. Drugs designated as breakthrough therapies by the FDA may be eligible for all features of Fast Track designation, intensive guidance on an efficient drug development program, beginning as early as Phase 1, and organizational commitment involving senior managers at FDA

  • NewRisks Related to Government Regulation

    such designation, we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity

  • NewRisks Related to Government Regulation

    be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval

  • NewRisks Related to Government Regulation

    Our collaboration with Novatim subjects us to risks and uncertainties relating to challenged and changing relations between the United States and China

  • NewRisks Related to Government Regulation

    U.S.-China trade relations may adversely impact our supply chain operations and business

  • NewRisks Related to Our Intellectual Property

    Our success depends in part on our ability to obtain, maintain and protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection

  • NewRisks Related to Our Intellectual Property

    In that event, we would be unable to further develop and commercialize our product candidates, which could significantly harm our business

  • NewRisks Related to Ownership of Our Common Stock and Other General Matters

    If the benefits of the Asset Acquisition do not meet the expectations of investors or securities analysts, the market price of our common stock may decline

  • NewRisks Related to Ownership of Our Common Stock and Other General Matters

    Our Chief Executive Officer and principal stockholder collectively own a substantial portion of our common stock

  • NewRisks Related to Ownership of Our Common Stock and Other General Matters

    our corporate financing activities

  • NewRisks Related to Our Status as a Public Company and Other General Matters

    If we are unable to maintain listing of our common stock on Nasdaq or any stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and it may be more difficult for our stockholders to sell their securities

Dropped

  • Dropped

    terms or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or our operations

  • Dropped

    The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates

    Operating losses and need for additional funding for research and development.

  • DroppedRisks Related to Our Financial Position and Capital Needs

    We will require significant additional funding to finance our operations, which may not be available on acceptable terms or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or our operations

  • DroppedRisks Related to Our Financial Position and Capital Needs

    the extent to which we acquire or in-license other product candidates and technologies

  • DroppedRisks Related to Our Financial Position and Capital Needs

    The terms of the Loan Agreement with Oxford provide Oxford with a lien against all of our assets, including our intellectual property, and contains financial covenants and other restrictions on our actions that may limit our operational flexibility or otherwise adversely affect our results of operations

  • DroppedRisks Related to Our Business and Strategy

    We expect to expand our development and regulatory capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations

  • DroppedRisks Related to Our Product Development and Regulatory Approval

    If we are unable to develop, obtain regulatory approval for and commercialize TPST-1495, amezalpat, or any of our future product candidates, or if we experience significant delays in doing so, our business will be materially harmed

  • DroppedRisks Related to Our Product Development and Regulatory Approval

    Success in preclinical studies and earlier clinical trials for our product candidates may not be indicative of the results that may be obtained in later clinical trials, which may delay or prevent obtaining regulatory approval

    Lengthy FDA regulatory approval process and protection of intellectual property.

  • DroppedRisks Related to Our Product Development and Regulatory Approval

    From time to time, we may publish interim or preliminary data from our clinical studies. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available

    Substantial cash consumption for clinical trials like Phase 3 in first-line HCC.

  • DroppedRisks Related to Government Regulation

    have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised

    Uncertainty of generating revenue from future product sales.

Reworded

  • 100% rewritten

    Summary of Selected Risks Associated with Our Business

    Added a summary reference to funding needs and business uncertainties.

  • 100% rewritten

    The trading price of the shares of our common stock has been and is likely to continue to be volatile, and purchasers of our common stock could incur substantial losses

    Replaced 2024 stock price range details with disclosures on a reverse stock split, thin trading, and stock liquidity.

  • 100% rewritten

    If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired

    Replaced internal control and Sarbanes-Oxley disclosures with Nasdaq listing compliance risks.

  • 100% rewritten

    Our success depends in part on our ability to obtain, maintain and protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection

    Added specific mentions of third-party collaboration and license agreements with Novatim and Factor.

  • 100% rewrittenRisks Related to Our Product Development and Regulatory Approval

    If we are unable to develop, obtain regulatory approval for and commercialize our product candidates, including TPST-2003, TPST-1495 and amezalpat, or any of our future product candidates, or if we experience significant delays in doing so, our business will be materially harmed

    Added TPST-2003, a dual-targeting CD19/BCMA CAR-T product for multiple myeloma, to lead product candidate disclosures.

    Was: If we are unable to develop, obtain regulatory approval for and commercialize amezalpat, TPST-1495, or any of our future product candidates, or if we experience significant delays in doing so, our business will be materially harmed

  • 93% rewrittenRisks Related to Commercialization and Manufacturing

    The pricing, insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate product revenue

    Maintained pricing and reimbursement uncertainty language for newly approved products.

  • 92% rewritten

    Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish proprietary rights

    Replaced Oxford loan agreement references with operating losses, funding needs, and asset acquisition integration risks.

  • 90% rewrittenRisks Related to Our Product Development and Regulatory Approval

    business interruptions resulting from geopolitical actions, including war and terrorism, natural disasters including earthquakes, typhoons, floods and fires, and public health crises

    Appended clinical trial unpredictability and expense details to geopolitical and natural disaster risks.

    Was: business interruptions resulting from geopolitical actions, including war and terrorism such as the Russia-Ukraine war and the war in Israel, natural disasters including earthquakes, typhoons, floods and fires, and public health crises

  • 88% rewrittenRisks Related to Government Regulation

    Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions

  • 84% rewrittenRisks Related to Government Regulation

    Changes in tax laws or regulations could materially adversely affect us

  • 83% rewrittenRisks Related to Government Regulation

    Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the denial of regulatory approval of our product candidates

  • 76% rewrittenRisks Related to Our Status as a Public Company and Other General Matters

    We expect to continue to incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance with our public company responsibilities and corporate governance practices

  • 72% rewritten

    We may rely on third parties to manufacture our clinical product supplies, and we may have to rely on third parties to produce and process our product candidates, if approved

  • 72% rewrittenRisks Related to Our Product Development and Regulatory Approval

    Our current and any future product candidates may cause undesirable and/or unforeseen side effects or be perceived by the public as unsafe, which could delay or prevent their advancement into clinical trials or regulatory approval, limit the commercial potential or result in significant negative consequences

    Was: TPST-1495, amezalpat and any future product candidates may cause undesirable and/or unforeseen side effects or be perceived by the public as unsafe, which could delay or prevent their advancement into clinical trials or regulatory approval, limit the commercial potential or result in significant negative consequences

  • 69% rewrittenRisks Related to Government Regulation

    Enacted and future legislation may increase the difficulty and cost for us to commercialize and obtain marketing approval of our product candidates and may affect the prices we may set

  • 52% rewrittenRisks Related to Commercialization and Manufacturing

    Our third-party manufacturers could breach or terminate their agreement(s) with us

  • 51% rewrittenRisks Related to Government Regulation

    If our information technology systems or those of third parties with whom we work, or our data, are or were compromised, we could experience adverse consequences, including disclosure of sensitive information, damage to our reputation, and significant financial and legal exposure

  • 51% rewritten

    If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenues

  • 49% rewrittenRisks Related to Ownership of Our Common Stock and Other General Matters

    Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price

  • 41% rewrittenRisks Related to Our Business and Strategy

    Our ability to utilize our net operating loss carryforwards and tax credit carryforwards may be subject to limitations

  • 34% rewrittenRisks Related to Government Regulation

    The FDA’s ability to review and approve new products may be hindered by a variety of factors, including budget and funding levels, ability to hire and retain key personnel, statutory, regulatory and policy changes and global health concerns

  • 34% rewrittenRisks Related to Our Product Development and Regulatory Approval

    the risk that patients enrolled in our clinical trials will drop out of the trials before the infusion of our product candidates or trial completion

  • 30% rewrittenRisks Related to Our Status as a Public Company and Other General Matters

    require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our certificate of incorporation or by-laws

  • 27% rewrittenRisks Related to Commercialization and Manufacturing

    The commercial success of our product candidates will depend upon their degree of market acceptance by providers, patients, patient advocacy groups, third-party payors and the general medical community

    Was: The commercial success of our product candidates, including TPST-1495 and amezalpat, will depend upon their degree of market acceptance by providers, patients, patient advocacy groups, third-party payors and the general medical community

  • 23% rewritten

    We may not be successful in our efforts to expand our pipeline of product candidates and develop marketable products

All 90 risk factors

Headings as the filing states them, in filing order.

Other

  1. 01Summary of Selected Risks Associated with Our Business100% rewritten
  2. 02Our business is subject to numerous risks and uncertainties, any one of which could materially adversely affect our business, financial condition, operating results, and prospects. You should read this summary together with the more detailed description of each risk factor contained belowNew
  3. 03Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish proprietary rights92% rewritten
  4. 04Interim and preliminary data from our or our licensors’ clinical trials that we may announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final dataNew
  5. 05We may not be successful in our efforts to expand our pipeline of product candidates and develop marketable products23% rewritten
  6. 06We may rely on third parties to manufacture our clinical product supplies, and we may have to rely on third parties to produce and process our product candidates, if approved72% rewritten
  7. 07If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenues51% rewritten
  8. 08Our success depends in part on our ability to obtain, maintain and protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection100% rewritten
  9. 09The trading price of the shares of our common stock has been and is likely to continue to be volatile, and purchasers of our common stock could incur substantial losses100% rewritten
  10. 10If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired100% rewritten

Risks Related to Our Financial Position and Capital Needs

  1. 11Our existing cash and cash equivalents of $7.7 million as of December 31, 2025 is expected to fund our operations through less than 12 months from the date our consolidated financial statements are available to be issuedNew
  2. 12In addition, if we raise additional capital through future collaborations, strategic alliances or third-party licensing arrangements, we may have to relinquish future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us
  3. 13Our ability to raise capital may be limited by applicable laws and regulations
  4. 14Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability

Risks Related to Our Business and Strategy

  1. 15Integrating the Assets with our business may be more difficult, costly or time consuming than expected and we may fail to realize the anticipated benefits of the Asset AcquisitionNew
  2. 16We are in the early stages of integrating the Assets into our business, and unknown or unanticipated risks associated with the Assets could adversely affect usNew
  3. 17We must attract and retain highly skilled employees to succeed
  4. 18We will need to expand our organization in the future, and we may experience difficulties in managing this growth, which could disrupt our operationsNew
  5. 19Future acquisitions or strategic alliances could disrupt our business and harm our financial condition and results of operations
  6. 20litigation or other claims in connection with the acquired company, including claims from terminated employees, customers, former stockholders or other third parties
  7. 21Our ability to utilize our net operating loss carryforwards and tax credit carryforwards may be subject to limitations41% rewritten

Risks Related to Our Product Development and Regulatory Approval

  1. 22If we are unable to develop, obtain regulatory approval for and commercialize our product candidates, including TPST-2003, TPST-1495 and amezalpat, or any of our future product candidates, or if we experience significant delays in doing so, our business will be materially harmed100% rewritten
  2. 23business interruptions resulting from geopolitical actions, including war and terrorism, natural disasters including earthquakes, typhoons, floods and fires, and public health crises90% rewritten
  3. 24If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
  4. 25the risk that patients enrolled in our clinical trials will drop out of the trials before the infusion of our product candidates or trial completion34% rewritten
  5. 26Moreover, because our product candidates represent unproven methods for cancer treatment, potential patients and their doctors may be inclined to use existing therapies rather than enroll patients in our clinical trialsNew
  6. 27We plan to work with our collaborator, Novatim, to conduct clinical trials for TPST-2003 and TPST-2206 outside the United States, including China, and the FDA and similar foreign regulatory authorities may not accept data from such trials conducted in locations outside of their jurisdictionNew
  7. 28Interim and preliminary data from our or our licensors' clinical trials that we may announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final dataNew
  8. 29We currently are investigating amezalpat and TPST-1495 in combination with other approved therapies, and we may in the future investigate product candidates in combination with other approved and unapproved therapies, which exposes us to additional risks
  9. 30Even if we complete the necessary preclinical studies and clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize a product candidate and the approval may be for a narrower indication than we seek
  10. 31the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval
  11. 32Our current and any future product candidates may cause undesirable and/or unforeseen side effects or be perceived by the public as unsafe, which could delay or prevent their advancement into clinical trials or regulatory approval, limit the commercial potential or result in significant negative consequences72% rewritten
  12. 33the product for distribution to patients and a communication plan to health care practitioners, or other elements to assure safe use of the productNew
  13. 34injunctions or the imposition of civil or criminal penalties
  14. 35Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the United States

Risks Related to Commercialization and Manufacturing

  1. 36The commercial success of our product candidates will depend upon their degree of market acceptance by providers, patients, patient advocacy groups, third-party payors and the general medical community27% rewritten
  2. 37The pricing, insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate product revenue93% rewritten
  3. 38other third-party payors. Even if coverage is provided, the established reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investmentNew
  4. 39Our future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our products
  5. 40Our third-party manufacturers could breach or terminate their agreement(s) with us52% rewritten
  6. 41the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for usNew
  7. 42We may not be successful in finding strategic collaborators for continuing development of certain of our future product candidates or successfully commercializing or competing in the market for certain indications

Risks Related to Government Regulation

  1. 43The FDA regulatory approval process is lengthy and time consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates
  2. 44Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the denial of regulatory approval of our product candidates83% rewritten
  3. 45effects observed early in clinical development. Drugs designated as breakthrough therapies by the FDA may be eligible for all features of Fast Track designation, intensive guidance on an efficient drug development program, beginning as early as Phase 1, and organizational commitment involving senior managers at FDANew
  4. 46such designation, we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivityNew
  5. 47Enacted and future legislation may increase the difficulty and cost for us to commercialize and obtain marketing approval of our product candidates and may affect the prices we may set69% rewritten
  6. 48The FDA’s ability to review and approve new products may be hindered by a variety of factors, including budget and funding levels, ability to hire and retain key personnel, statutory, regulatory and policy changes and global health concerns34% rewritten
  7. 49If our information technology systems or those of third parties with whom we work, or our data, are or were compromised, we could experience adverse consequences, including disclosure of sensitive information, damage to our reputation, and significant financial and legal exposure51% rewritten
  8. 50Our employees, principal investigators, CROs, CMOs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
  9. 51Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions88% rewritten
  10. 52be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approvalNew
  11. 53If we fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business
  12. 54Although we maintain workers’ compensation insurance to cover for costs and expenses, we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities
  13. 55Changes in tax laws or regulations could materially adversely affect us84% rewritten
  14. 56Our collaboration with Novatim subjects us to risks and uncertainties relating to challenged and changing relations between the United States and ChinaNew
  15. 57U.S.-China trade relations may adversely impact our supply chain operations and businessNew

Risks Related to Our Intellectual Property

  1. 58Our success depends in part on our ability to obtain, maintain and protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protectionNew
  2. 59the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us
  3. 60Our owned and in-licensed patents and patent applications may not provide sufficient protection of our product candidates or result in any competitive advantage
  4. 61Our strategy of obtaining rights to key technologies through in-licenses may not be successful
  5. 62If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
  6. 63Third-party claims of intellectual property infringement may prevent, delay or otherwise interfere with our product discovery and development efforts
  7. 64there could be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock
  8. 65In that event, we would be unable to further develop and commercialize our product candidates, which could significantly harm our businessNew
  9. 66We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful and could result in a finding that such patents are unenforceable or invalid
  10. 67We may not be able to protect our intellectual property rights throughout the world
  11. 68Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets
  12. 69Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
  13. 70As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain
  14. 71Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
  15. 72If we do not obtain patent term extension for any product candidates we may develop, our business may be materially harmed

Risks Related to Ownership of Our Common Stock and Other General Matters

  1. 73If the benefits of the Asset Acquisition do not meet the expectations of investors or securities analysts, the market price of our common stock may declineNew
  2. 74period-to-period fluctuations in our financial results
  3. 75Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price49% rewritten
  4. 76Our common stock is thinly traded and our stockholders may be unable to sell their shares quickly or at market price
  5. 77We are a smaller reporting company, and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors
  6. 78Our Chief Executive Officer and principal stockholder collectively own a substantial portion of our common stockNew
  7. 79our corporate financing activitiesNew

Risks Related to Our Status as a Public Company and Other General Matters

  1. 80We expect to continue to incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance with our public company responsibilities and corporate governance practices76% rewritten
  2. 81If we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act, in a timely manner, or if we are unable to maintain proper and effective internal controls, we may not be able to accurately report our financial condition, results of operations or cash flows
  3. 82If we are unable to maintain listing of our common stock on Nasdaq or any stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and it may be more difficult for our stockholders to sell their securitiesNew
  4. 83We or the third parties upon whom we depend may be adversely affected by natural disasters and other calamities, including public health crises, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
  5. 84Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could have a material and adverse effect on our business, financial condition, results of operations and prospects
  6. 85the inability to commercialize any product candidates that we may develop
  7. 86Provisions in our certificate of incorporation and by-laws and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
  8. 87require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our certificate of incorporation or by-laws30% rewritten
  9. 88Our bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees
  10. 89We do not anticipate that we will pay any cash dividends in the foreseeable future
  11. 90If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline

Other Tempest Therapeutics 10-Ks

  • FY2024 10-K risk factors
    77 risks

    Tempest Therapeutics faces primary risks from its heavy reliance on two unapproved lead product candidates, amezalpat and TPST-1495. The company requires significant ongoing capital and debt financing, pledging all assets including intellectual property to Oxford Finance. Clinical development, trial patient enrollment, and third-party manufacturing dependencies present continuous operational threats.

    Filed Mar 27, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.